Delivery devices

ABSTRACT

A delivery device for delivering a metered amount of substance (L) in response to exhalation by a user, the delivery device comprising: a mouthpiece ( 5 ) through which the user in use exhales; an outlet ( 45 ) from which substance Is delivered; and a dispensing unit ( 35 ) which is operable to dispense a metered amount of substance through the outlet in response to exhalation by the user through the mouthpiece, wherein the dispensing unit comprises a body member ( 37 ) which includes a cavity ( 39 ) for containing a metered amount of substance, an outlet nozzle ( 43 ) which is fluidly connected to the cavity from which substance is in use delivered, and a dispensing ( 41 ) member which is movably disposed in the cavity and configured to be driven through the cavity by a driving pressure created by exhalation of the user, such as to cause substance to be delivered from the outlet nozzle.

This application is a continuation application of U.S. application Ser.No. 14/171,554, filed on Feb. 3, 2014, which is a continuationapplication of U.S. application Ser. No. 12/516,401, filed on Jul. 12,2010, now abandoned, which is a U.S. national phase application ofPCT/IB2007/004353, filed on Nov. 28, 2007, which claims priority to GB0623731.7, filed on Nov. 28, 2006.

The present invention relates to a delivery device for and method ofdelivering a metered volume of substance, in particular a deliverydevice for delivering a metered volume of a liquid substance to a nasalcavity of a subject.

Very many delivery devices exist for the delivery of liquid substances,which typically comprise a manually-actuated pump for the delivery of aliquid substance as an aerosol spray.

Whilst these delivery devices have found extensive application, thepresent inventors have recognized the need for a delivery device whichutilizes the exhalation breath of a user as the driving force to delivera metered dose of a liquid substance.

In one aspect the present invention provides a delivery device fordelivering a metered amount of substance in response to exhalation by auser, the delivery device comprising: a mouthpiece through which theuser in use exhales; an outlet from which substance is delivered; and adispensing unit which is operable to dispense a metered amount ofsubstance through the outlet in response to exhalation by the userthrough the mouthpiece, wherein the dispensing unit comprises a bodymember which includes a cavity for containing a metered amount ofsubstance, an outlet nozzle which is fluidly connected to the cavityfrom which substance is in use delivered, and a dispensing member whichis movably disposed in the cavity and configured to be driven throughthe cavity by a driving pressure created by exhalation of the user, suchas to cause substance to be delivered from the outlet nozzle.

In one embodiment the cavity is an elongate cavity.

In one embodiment the cavity has a cylindrical section and thedispensing member comprises a ball which is moved along the cavity bythe driving pressure created by exhalation of the user.

In one embodiment the ball sealingly engages with an inner peripheralwall of the cavity.

In one embodiment the cavity and the dispensing member are configured toprovide for movement of the dispensing member at a driving pressure ofless than about 5 kPa, and preferably less than about 3 kPa.

In one embodiment the outlet nozzle provides for an aerosol spray.

In one embodiment the outlet nozzle provides for a substantiallyrectilinear flow for a distance of at least about 15 mm, preferably atleast about 20 mm, more preferably at least about 25 mm and yet morepreferably at least about 30 mm from exit of the outlet nozzle.

In another embodiment the outlet nozzle provides for a jet.

In one embodiment the delivery device further comprises: a pressureregulator which is fluidly connected to the dispensing unit, such as toprovide for application of a predeterminable driving pressure to thedispensing member.

In one embodiment the mouthpiece and the outlet are fluidly connected,such as to provide for an air flow through the outlet on exhalation bythe user through the mouthpiece.

In one embodiment the delivery device further comprises: a housing inwhich the dispensing unit is disposed and to which the mouthpiece andthe nosepiece are fluidly connected, such as to define a fluidcommunication path therebetween.

In one embodiment the delivery device further comprises: a baffle memberwhich is disposed in the fluid communication path.

In one embodiment the baffle member includes a first, driving airpressure channel which is fluidly connected to the dispensing unit andat which the driving pressure is created on exhalation by the user toactuate the dispensing unit, and at least one second, entraining airflow channel through which an entraining air flow is delivered forentraining substance as delivered by the dispensing unit.

In one embodiment the baffle member includes a plurality of entrainingair flow channels.

In one embodiment the housing includes an inlet chamber upstream of thebaffle member which flares outwardly from the mouthpiece.

In one embodiment the housing includes an outlet chamber downstream ofthe baffle member.

In one embodiment the outlet chamber surrounds the dispensing unit.

In one embodiment the outlet includes a flow restrictor for providing aflow restriction thereat.

In one embodiment the flow restrictor tapers inwardly in a flowdirection from the mouthpiece to the nosepiece.

In one embodiment the flow restrictor has a frusto-conical section.

In one embodiment the delivery device further comprises: a flowregulator which is disposed at the outlet nozzle of the dispensing unit.

In one embodiment the flow regulator includes a plurality of flowapertures which are located on an annulus surrounding the outlet nozzle.

In one embodiment the delivery device is configured to deliver a liquid.

In one embodiment the outlet is a nosepiece and the delivery device is anasal delivery device for delivering substance to a nasal airway of asubject.

A preferred embodiment of the present invention will now be describedhereinbelow by way of example only with reference to the accompanyingdrawings, in which:

FIG. 1 illustrates a part-sectional perspective view of a deliverydevice in accordance with a preferred embodiment of the presentinvention;

FIG. 2 illustrates a longitudinal sectional view of the delivery deviceof FIG. 1, where in the rest or non-actuated state;

FIGS. 3(a) to (c) illustrate three delivery profiles for the deliveredsubstance obtainable by the delivery device of FIG. 1;

FIG. 4 illustrates the delivery device of FIG. 1, where in the actuatedstate;

FIG. 5 illustrates a part-sectional perspective view of a deliverydevice as a modification of the delivery device of FIG. 1; and

FIG. 6 illustrates a longitudinal sectional view of the delivery deviceof FIG. 5.

The delivery device comprises a first, inlet housing part 3 whichdefines a mouthpiece 5 at one, inlet end thereof and an inlet chamber 7which is in fluid communication with the mouthpiece 5 and the other,outlet end of which is open, such that exhalation by a user into themouthpiece 5 delivers an air flow into the inlet chamber 7 and to theopen, outlet end thereof.

In this embodiment the mouthpiece 5 comprises a tubular section which isgripped in the lips of the user.

In this embodiment the inlet chamber 7 flares outwardly from themouthpiece 5, here having a frusto-conical section.

The delivery device further comprises a baffle member 11 which sealinglyengages the open, outlet end of the inlet chamber 7, such as to directthe air flow as delivered through the inlet chamber 7.

The baffle member 11 includes a first, driving air pressure channel 21at which a driving pressure is created, which acts to drive a liquiddispensing unit 35, as will be described in more detail hereinbelow, andat least one, in this embodiment a plurality of second, entraining airflow channels 23 through which an entraining air flow F is delivered.

In this embodiment the first, driving air pressure channel 21 is locatedon the longitudinal axis of the inlet chamber 7. In this embodiment thedriving air pressure channel 21 has a circular section, here having adiameter of at or less than about 6 mm.

In this embodiment the entraining air flow channels 23 are located suchas to be in fluid communication with the periphery of the open, outletend of the inlet chamber 7. In this embodiment the baffle member 11includes four entraining air flow channels 23 which are disposeduniformly on an annulus about the longitudinal axis of the inlet housingpart 3, and each have a circular section, here having a diameter of ator less than about 4 mm.

In this embodiment the baffle member 11 comprises first and secondbaffle elements 25, 27, here plates which are disposed in juxtaposedrelation.

The delivery device further comprises a pressure regulator 29 whichincludes an aperture 31 which is fluidly connected to the driving airpressure channel 21 in the baffle member 11, in this embodiment at thedownstream end thereof, such as to provide for the generation of apredetermined pressure thereat. In this embodiment the aperture 31 has acircular section, here having a diameter of at or less than about 4 mm.

The delivery device further comprises a liquid dispensing unit 35 whichis fluidly connected to the pressure regulator 29 such as to be actuatedby the driving air pressure P as generated on exhalation by the userthrough the mouthpiece 5.

The liquid dispensing unit 35 comprises a body member 37, in thisembodiment a tubular member, here of cylindrical section, which definesan elongate cavity 39 which contains a metered dose of a liquid L, adispensing member 41 which is movably disposed in the cavity 39, such asto be moved along the cavity 39 under the action of the driving airpressure P and thereby dispense the liquid L from the cavity 39, and anoutlet nozzle 43 which is configured to provide for dispensing of theliquid L at a predetermined rate.

In this embodiment the cavity 39 has a volume of about 1 ml. In anotherembodiment the cavity 39 could have a volume of or less than about 200μl.

In this embodiment the dispensing member 41 is initially disposed at oneend of the cavity 39 adjacent the flow regulator 29 and is moved to theother end of the cavity 39 under the action of the driving air pressure,with the liquid L as contained in the cavity 39 being progressivelydispensed as the dispensing member 41 is moved along the cavity 39.

In this embodiment the dispensing member 41 and the cavity 39 of theliquid dispensing unit 35 are configured to provide for movement with adriving air pressure P at or less than about 5 kPa and preferably at orless than about 3 kPa.

In this embodiment the dispensing member 41 is a ball which sealinglyengages the peripheral wall of the cavity 39.

The outlet nozzle 43 includes an outlet orifice 45 which is shaped anddimensioned, in this embodiment having a circular section, to providethe dispensed liquid with a predetermined profile. In this embodimentthe outlet orifice 45 is configured to dispense the liquid L such thatthe flow of liquid L remains substantially rectilinear for a distance ofat least about 15 mm, preferably at least about 20 mm, more preferablyat least about 25 mm and yet more preferably at least about 30 mm fromthe exit of the outlet orifice 45 and thereafter provide a dispersedaerosol spray, as illustrated in FIG. 3(a). In an alternative embodimentthe outlet orifice 45 can be configured to provide a liquid jet, eitherwith some dispersion in the form of a shower of droplets, as illustratedin FIG. 3(b), or with no dispersion, as illustrated in FIG. 3(c).

In preferred embodiments the outlet orifice 45 has a diameter of at orless than about 3 mm, preferably at or less than about 2 mm, and morepreferably at or less than about 1 mm.

In this embodiment the outlet nozzle 43 includes a frangible membranewhich normally encloses the outlet orifice 45 thereof such as to containthe liquid L and is ruptured on the application of the driving airpressure P to the liquid L.

The delivery device further comprises a second, outlet housing part 51which defines a nosepiece 53 at one, outlet end thereof and an outletchamber 57, in this embodiment an annular chamber surrounding the bodymember 37 of the liquid dispensing unit 35, which is in fluidcommunication with the entraining air flow channels 23 in the bafflemember 11 and opens to an outlet end thereof, such that exhalation by auser into the mouthpiece 5 delivers an entraining air flow F into theoutlet chamber 57 and to the open, outlet end thereof.

The delivery device further comprises a flow regulator 61 which enclosesthe annular outlet chamber 57 at the outlet end of the body member 37 ofthe liquid dispensing unit 35.

In this embodiment the flow regulator 61 includes a plurality of flowapertures 63, in this embodiment sixteen apertures, which are located onan annulus surrounding the body member 37 of the liquid dispensing unit35, such as to provide for the delivery of a substantially annularentraining air flow F which entrains the liquid L as dispensed from theliquid-containing cavity 39 of the liquid dispensing unit 35.

In this embodiment the flow regulator 61 is configured to provide for aflow rate of at least about 20 l/mm, more preferably at least about 30l/mm, still more preferably at least about 40 l/min and yet morepreferably at least about 50 l/mm.

In this embodiment the flow apertures 63 have a circular section, hereof a diameter of at or less than about 1 mm.

Operation of the above-described delivery device will now be describedhereinbelow with reference to FIG. 4 of the accompanying drawings.

A user first inserts the nosepiece 53 into one of his/her nostrils andthen grips the mouthpiece 5 in his/her lips. It should be understoodthat, for the sake of ease of illustration, the delivery device has beenillustrated in an elongate configuration where the nosepiece 53 and themouthpiece 5 are located on a common axis. In practice, the nosepiece 53and the mouthpiece 5 would be inclined relative to one another, such asto facilitate fitting of the nosepiece 53 and the mouthpiece 5 inrespective ones of a nostril and the lips.

The user then exhales through the mouthpiece 5, which is in fluidcommunication with the inlet chamber 7.

This exhalation acts to generate a driving air pressure P at the drivingair pressure channel 21 in the baffle member 11 and an entraining airflow F through the entraining air flow channels 23 in the baffle member11, which entraining air flow F continues through the outlet chamber 57and the flow apertures 63 in the entraining air flow regulator 61, whichdefine a substantially annular entraining air flow F which surrounds theoutlet end of the liquid dispensing unit 35.

The driving air pressure P as created at the driving air pressurechannel 21 simultaneously acts on the dispensing member 41, which islocated in the cavity 39 of the liquid dispensing unit 35, such as tomove the same along the cavity 39 and dispense the liquid L as containedtherein from the outlet end thereof into the entraining air flow F,which surrounds the same, thereby providing for delivery of the liquidL, in this embodiment into the nasal cavity of the user.

In this embodiment the delivery device, in providing for the delivery ofthe liquid L in an entraining air flow F, advantageously provides fordelivery into and through the nasal airway in the manner as described inthe applicant's earlier WO-A-2000/051672, the content of which is hereinincorporated by reference.

Finally, it will be understood that the present invention has beendescribed in its preferred embodiment and can be modified in manydifferent ways without departing from the scope of the invention asdefined by the appended claims.

In one modification, as illustrated in FIGS. 5 and 6, the deliverydevice can further comprise a flow restrictor 71 at the outlet end ofthe outlet housing part 51 which defines the nosepiece 53. In thisembodiment the flow restrictor 71 tapers inwardly, here with afrusto-conical section 73, towards the outlet end of the outlet housingpart 51. In this embodiment the flow restrictor 71 defines an outletwhich has a circular section. In preferred embodiments the outlet of theflow restrictor 71 has a diameter of at or less than about 8 mm,preferably at or less than about 6 mm and more preferably at or lessthan about 4 mm, and the angle of the tapering section 73 of the flowrestrictor 71 has an angle of at or less than about 60 degrees,preferably at or less than about 55 degrees and more preferably at orless than about 52 degrees relative to a plane perpendicular to thelongitudinal axis of the outlet housing part 51. With thisconfiguration, a faster delivery of the liquid L can be achieved ascompared to the above-described embodiment.

1. A delivery device for delivering a metered amount of a substance inresponse to exhalation by a user, the delivery device comprising: amouthpiece adapted for a user to exhale through; an outlet from whichthe substance is delivered; and a dispensing unit operable to dispense ametered amount of the substance through the outlet in response toexhalation by the user through the mouthpiece, wherein the dispensingunit comprises a body member, the body member including a cavity forcontaining a metered amount of the substance, an outlet nozzle fluidlyconnected to the cavity from which the substance is delivered, and adispensing member movably disposed in the cavity and configured to bedriven through the cavity by a driving pressure created by exhalation ofthe user, causing substance to be delivered from the outlet nozzle;whereby the exhalation of the user creates an exhalation flow thatdirectly acts on the dispensing member.
 2. The delivery device of claim1, wherein the cavity is an elongate cavity.
 3. The delivery device ofclaim 2, wherein the cavity has a cylindrical section and the dispensingmember comprises a ball.
 4. The delivery device of claim 3, wherein theball sealingly engages an inner peripheral wall of the cavity.
 5. Thedelivery device of claim 1 4, wherein the dispensing member isconfigured to move within the cavity at a driving pressure of less than5 kPa.
 6. The delivery device of claim 1, wherein the outlet nozzle isconfigured to deliver an aerosol spray.
 7. The delivery device of claim6, wherein the outlet nozzle provides for a substantially rectilinearflow for a distance of at least 30 mm from an exit of the outlet nozzle.8. The delivery device of claim 1, wherein the outlet nozzle isconfigured to deliver a jet.
 9. The delivery device of claim 1, furthercomprising: a pressure regulator fluidly connected to the dispensingunit and configured to apply a predeterminable driving pressure to thedispensing member.
 10. (canceled)
 11. The delivery device of claim 1,further comprising: a housing defining a fluid communication pathbetween the mouthpiece and the nosepiece.
 12. The delivery device ofclaim 11, further comprising: a baffle member disposed in the fluidcommunication path.
 13. The delivery device of claim 12, wherein thebaffle member includes a first, driving air pressure channel fluidlyconnected to the dispensing unit and at least one second, entraining airflow channel fluidly connected to the mouthpiece through which anentraining air flow is delivered for entraining the substance asdelivered by the dispensing unit.
 14. The delivery device of claim 13,wherein the baffle member includes a plurality of entraining air flowchannels.
 15. The delivery device of claim 12, wherein the housingincludes an inlet chamber upstream of the baffle member and downstreamof the mouthpiece which flares outwardly from the mouthpiece toward thebaffle member.
 16. The delivery device of claim 12, wherein the housingincludes an outlet chamber downstream of the baffle member.
 17. Thedelivery device of claim 16, wherein the outlet chamber surrounds thedispensing unit.
 18. The delivery device of claim 10, wherein the outletincludes a flow restrictor.
 19. The delivery device of claim 18, whereinthe flow restrictor tapers inwardly.
 20. The delivery device of claim19, wherein the flow restrictor has a frusto-conical section.
 21. Thedelivery device of claim 17, further comprising: an annulus surroundingthe outlet nozzle of the dispensing unit and positioned radially betweenthe dispensing unit and the housing.
 22. The delivery device of claim21, wherein the annulus includes a plurality of flow apertures.
 23. Thedelivery device of claim 1, where the delivery device is configured todeliver a liquid.
 24. The delivery device of claim 1, wherein the outletis a nosepiece and the delivery device is a nasal delivery device fordelivering the substance to a nasal airway of a user.
 25. (canceled)